Safety and immunovirologic outcomes with maraviroc combination regimens in patients with a history of past treatment failures and virologic resistance in Brazil: an open-label, multicenter phase 3b study.

Maraviroc is a first-in-class chemokine coreceptor type-5 (CCR5) antagonist with demonstrated immunovirologic activity in treatment-experienced (TE) patients with CCR5 (R5)-tropic HIV-1; however, experience in regimens containing newer antiretroviral agents is limited. The primary objective of this 96-week open-label, noncomparative, multicenter Phase 3b study (NCT00478231) was to assess the safety of maraviroc in combination with optimized background therapy (OBT), which could include recently introduced agents such as darunavir and raltegravir in TE patients in Brazil with R5 HIV-1 and limited therapeutic options. Immunovirologic activity was a secondary endpoint. Of 638 patients screened, 206 were treated and 125 completed the study. Approximately 70% were male; the mean age was 43.2 years. Most patients (65.0%) received an OBT combination of protease inhibitor plus nucleoside reverse transcriptase inhibitor. Adverse event (AE) and treatment-related AE incidence was 91.3% and 36.9%, respectively. The most common AEs were diarrhea, nasopharyngitis, and headache. Serious AEs and treatment-related serious AEs occurred in 16.5% and 4.4% of patients. Only eight patients (3.9%) discontinued due to AEs. Few AIDS-defining events were observed (4.9%). The proportion of patients with viral load <400 copies/ml increased from 2.4% at baseline to 43.9% at week 8, remaining >40% until week 48. At the end of treatment, 26.7% of patients had a viral load <400 copies/ml. Median CD4(+) cell count increased throughout the study; the mean change from baseline to end of treatment was 174.1 cells/µl. In conclusion, maraviroc, combined with different agents from multiple classes, was well tolerated in highly TE patients. Maraviroc plus OBT was associated with an immunovirologic response in this population.

Prevalence of sorologic markers of HBV and HCV infection in HIV-1 seropositivr patients in Florionópolis, Brazil

B and C hepatitis are infections transmitted in ways similar to the human immunodeficiency virus (HIV). The present study was designed to assess the prevalence of hepatitis B (HBV) and hepatitis C (HCV) virus infection in HIV-1-infected patients who lived in the metropolitan areas of Florianópolis, in the State of Santa Catarina. Ninety-three patients seropositive to HIV-1 were identified by using enzyme-linked immunosorbent assay (ELISA) and indirect immunofluorescence. Patients were assigned to according to HIV-1 transmission risk: homosexuals (n=20), heterosexuals (n=39), and intravenous drugs users (IVDU) (N=34). HbsAg, Anti-HBc, Anti-HBc IgM and Anti-HCV measurements were done using ELISA. HBV and HCV prevalence in HIV-1 infected patients was 71 percen and 53.8 percent, respectively. In the IVDU group, the prevalence of HBV (85.3 percent), of HCV (88.2 percent), and infections by both viruses (76.5 percent) was greater than that observed in the heterosexual and homosexual groups. Hepatitis B markers (HbsAg and Anti-HBc) for chronic persistent disease were recorded in 24.3 percent of patients, and for past infection in 71.2 of patients. The evidence of high prevalence of HBV and HCV infections in HIV-1 seropositive patients, mainly among intravenous drug users, should be included in educational programs in an effort to decrease the incidence of multiple infections.

Risco profissional e profilaxia nosocomial de AIDS e Hepatite B / Professional risks and nosocomial prophylaxis of AIDS and Hepatites B

Avaliamos prospectiamente 140 profissionais da area da saude do Hospital Nereu Ramos (Florianopolis-SC), com o objetivo de avaliar o risco nosocomial de infeccao pelo virus da Hepatite B (HBV) e pelo virus da imunodeficiencia humana (HIV), atraves da realizacao de HBsAg, Anti-HBs e Anti-HIV. Aqueles que se mostrassem negativos para todos os marcadores do HBV eram questionados quanto a realizacao da vacina recombinante contra a hepatite B (Engerix B), e submetidos a esta caso a resposta fosse positiva. Dos 140 profissionais, encontrou-se um total de 17 (12,14 por cento) com algum marcador positivo para o HBV, destes 02 (1,42 por cento) HBsAg positivo e 15 (10,72 por cento) anti-HBs positivo; nenhum deles mostrou-se positivo para anti-corpo anti-HIV por ELISA. Dos 123 aptos a vacina, apenas 14 completaram as 03 doses, por dificuldade de obtencao da terceira dose. Negaram-se a realizacao da vacina 23 pessoas. A soroconversao foi de 100//e a incidencia de efeitos colaterais relatados na totalidade dos vacinados foi de 5 por cento. O numero de exposicoes acidentais a fluidos organicos foi de 12 casos de picada por agulha. Tambem comentamos a respeito da profilaxia de pre e pos exposicao nosocomial a agentes infecciosos, em especial o HBV e o HIV, tecendo tambem consideracoes a respeito de questoes eticas que envolvem o contato com pacientes soropositivos ou pertencentes a grupos de risco.